Clearside Biomedical Featured at Multiple European Scientific Retinal Congresses
September 19 2019 - 7:05AM
Clearside Biomedical, Inc. (Nasdaq:CLSD), a biopharmaceutical
company dedicated to developing and delivering treatments that
restore and preserve vision for people with serious back of the eye
diseases, announced today that numerous presentations were given at
three scientific congresses in Europe over the past two weeks.
“Clearside was well represented at three
prominent medical meetings in Europe with featured presentations on
gene therapy delivery, additional analysis of our
XIPERE™ clinical programs, and the unmet need in diabetic
macular edema,” said Thomas A. Ciulla, M.D., MBA, Chief Medical
Officer. “We were pleased to be a part of the numerous discussions
around gene therapy and the potential for suprachoroidal delivery
to enhance treatment options in this area. The uveitis and retina
communities are increasingly supportive of our efforts to bring
XIPERE to market, if approved, for their uveitis patients, as well
as our progress in gene therapy, small molecules, and delivery of
ocular oncology therapies. We look forward to working closely with
our partners and seeking indications internally to expand our
pipeline.”
Conference: Ophthalmology Futures Forum, Retina 2019,
September 3, 2019, Paris, France |
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Session: |
Safety, Vectors and Routes of
Delivery for Stem Cells and Gene Therapy |
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Summary: |
Clearside’s Dr. Thomas Ciulla
joined other academic and industry experts in the discussion of
stem cells and gene therapy. The session reviewed novel endpoints,
immune responses, and delivery methods for gene therapy,
highlighting suprachoroidal administration and its potential for
enhanced patient access to office-based gene therapy, as well as
the potential for enhanced delivery to the retina. |
Conference: European Society of Retina
Specialists EURETINA 2019 Congress, September 5-8, 2019, Paris,
France |
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Title: |
Suprachoroidal CLS-TA
Improves Patient Outcomes in Uveitis of All Anatomic Subtypes:
Results of the Phase 3 PEACHTREE Study |
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Author: |
Ron Neumann, M.D., Co-Chairperson
ISOPT Clinical, Ocular Drug Development Expert |
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Summary: |
Dr. Neumann presented an
electronic poster for the event reviewing the results of
Clearside’s Phase 3, PEACHTREE study for
XIPERE™ (triamcinolone acetonide suprachoroidal injectable
suspension), formerly known as CLS-TA. The PEACHTREE study was the
first pivotal trial specifically studying macular edema due to
non-infectious uveitis and the first uveitis trial with a primary
endpoint of visual acuity, a significant and clinically meaningful
outcome for both physicians and patients. The 96 patients treated
with suprachoroidally injected CLS-TA had been diagnosed with
non-infectious uveitis involving any anatomic location, reflective
of clinical practice. The primary endpoint of the trial was met
with nearly 1 of 2 patients experiencing a 3-line visual gain, and
1 of 2 patients experiencing resolution of macular edema. The
results were consistent regardless of the anatomical location of
the uveitis. There were no serious adverse events attributable to
CLS-TA, and there were low rates of elevated intraocular pressure.
Cataract adverse events were similar between treatment and control
groups and the vast majority of CLS-TA patients did not need rescue
therapy. |
Conference:
The Retina Society 52nd Scientific Program, September 11-15, 2019
London, UK |
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Title: |
Suprachoroidal
Triamcinolone Acetonide Suspension (CLS-TA) and Intraocular
Pressure: Results from the Phase 3 PEACHTREE Clinical Trial for
Uveitis |
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Author: |
Pauline Merrill, M.D., Illinois
Retina Associates, Rush University Medical Center |
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Summary: |
Dr. Merrill gave an extensive
presentation on the results of PEACHTREE with a focus on
intraocular pressure (IOP). With respect to IOP-related adverse
events (AEs), the rate was 12% in the suprachoroidal CLS-TA
treatment group compared to 16% in the control group. Rescue
medications were required in 72% of the patients in the control
group. Ten patients in the control group experienced
IOP-related AEs and each received intravitreal steroids as their
rescue therapy. There were no glaucoma surgeries in either group.
Further analysis found that IOP ≥ 30mmHg was observed in 5% of
CLS-TA treated eyes (n=83) compared to 11% of the control eyes
which received rescue treatment (n=46). Similarly, IOP lowering
medications were used in fewer eyes treated with suprachoroidal
triamcinolone acetonide (7%) compared to the control eyes receiving
rescue treatment (13%). |
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Title: |
Suprachoroidal Injection
of CLS-TA in Uveitis Maintains Efficacy Outcomes Through 48-weeks:
Results of the MAGNOLIA Phase 3 Extension Study |
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Author: |
Sumit Sharma, M.D., Vitreoretinal
Surgery and Uveitis Physician, Cleveland Clinic |
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Summary: |
In the MAGNOLIA extension study,
CLS-TA-treated patients maintained mean improvements of 12 letters
through week 48 after their initial treatment. Half of patients did
not require additional medication 36 weeks after their last
injection of CLS-TA. |
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Title: |
Visual Acuity
Outcomes and Anti-Vascular Endothelial Growth Factor Therapy
Intensity in Diabetic Macular Edema: A “Real World” Analysis in
28,456 Eyes |
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Author: |
Thomas A Ciulla, M.D., MBA,
Clearside Chief Medical Officer |
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Summary: |
Although the introduction of
anti-VEGF agents has led to notably improved outcomes for patients
with diabetic macular edema (DME), there are several practical
limitations, including the need for frequent injections and
incomplete response in some patients. Consequently, “real world”
DME treatment compliance can be poor. This analysis of 28,456 eyes
showed that “real world” DME patients are under-treated and their
resulting visual outcomes following anti-VEGF therapy are
meaningfully less than those seen in clinical trials. This analysis
demonstrates a large unmet need for DME therapies that address
treatment burden and incomplete response. |
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These presentations will be available on Clearside’s website in
the Publications section under Programs
(https://www.clearsidebio.com/publications.htm).
About XIPERE™
XIPERE™ (triamcinolone acetonide
suprachoroidal injectable suspension), formerly known as CLS-TA, is
a proprietary suspension of the corticosteroid triamcinolone
acetonide formulated for administration to the back of the eye for
the treatment of macular edema associated with uveitis. Clearside’s
patented technology is designed to deliver drug to the
suprachoroidal space located between the choroid and the outer
protective layer of the eye, known as the sclera. Suprachoroidal
injection enables the rapid and adequate dispersion of medicine to
the back of the eye, offering the potential for the medicine to act
longer and minimize harm to the surrounding healthy parts of the
eye, thus potentially providing advantageous and sustained efficacy
with a favorable safety profile.
About PEACHTREE
PEACHTREE, a randomized, masked, sham-controlled
Phase 3 trial, enrolled 160 patients with macular edema associated
with non-infectious uveitis, and compared XIPERE dosed every 12
weeks to sham control. The PEACHTREE trial met its primary
endpoint, with 47% of patients in the XIPERE arm gaining at least
15 letters in best corrected visual acuity from baseline at week
24, compared to 16% of patients in the sham control arm
(p<0.001), using standardized Early Treatment of Diabetic
Retinopathy Study (ETDRS) visual acuity testing. All key secondary
and additional endpoints of the PEACHTREE trial were also
achieved.
About Clearside Biomedical
Clearside Biomedical, Inc. is a
biopharmaceutical company dedicated to developing and delivering
treatments that restore and preserve vision for people with serious
back of the eye diseases. Clearside’s proprietary SCS
Microinjector™ targeting the suprachoroidal space (SCS) offers
unique access to the macula, retina and choroid where
sight-threatening disease often occurs. The Company’s SCS injection
platform is an inherently flexible, in-office, non-surgical
procedure, intended to provide targeted delivery to the site of
disease and to work with both established and new formulations of
medications, as well as future therapeutic innovations such as gene
therapy. For more information, please visit
www.clearsidebio.com.
Cautionary Note Regarding
Forward-Looking Statements
Any statements contained in this press release
that do not describe historical facts may constitute
forward-looking statements as that term is defined in the Private
Securities Litigation Reform Act of 1995. These statements may be
identified by words such as “believe”, “expect”, “may”, “plan”,
“potential”, “will”, and similar expressions, and are based on
Clearside’s current beliefs and expectations. These forward-looking
statements include statements regarding the potential to bring
XIPERE to market for uveitis patients, opportunities for expanding
Clearside’s internal pipeline, and the potential benefits of XIPERE
and the SCS injection platform. These statements involve risks and
uncertainties that could cause actual results to differ materially
from those reflected in such statements. Risks and uncertainties
that may cause actual results to differ materially include
uncertainties inherent in the conduct of clinical trials,
Clearside’s reliance on third parties over which it may not always
have full control, and other risks and uncertainties that are
described in Clearside’s Annual Report on Form 10-K for the year
ended December 31, 2018, filed with the U.S. Securities and
Exchange Commission (“SEC”) on March 15, 2019, Clearside’s
Quarterly Report on Form 10-Q for the quarter ended June 30, 2019,
filed with the SEC on August 8, 2019, and Clearside’s other
Periodic Reports filed with the SEC. Any forward-looking statements
speak only as of the date of this press release and are based on
information available to Clearside as of the date of this release,
and Clearside assumes no obligation to, and does not intend to,
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
Investor and Media Contacts: Jenny Kobin Remy
Bernarda ir@clearsidebio.com(678) 430-8206
Source: Clearside Biomedical, Inc.
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